| Nutritional supplement for lowering serum triglyceride and cholesterol levels -> Monitor Keywords |
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Nutritional supplement for lowering serum triglyceride and cholesterol levelsRelated Patent Categories: Drug, Bio-affecting And Body Treating Compositions, Designated Organic Active Ingredient Containing (doai), Cyclopentanohydrophenanthrene Ring System Doai, With Additional Active IngredientNutritional supplement for lowering serum triglyceride and cholesterol levels description/claimsThe Patent Description & Claims data below is from USPTO Patent Application 20060217356, Nutritional supplement for lowering serum triglyceride and cholesterol levels. Brief Patent Description - Full Patent Description - Patent Application Claims
FIELD OF THE INVENTION [0001] The invention relates to control of cholesterol and triglyceride levels in mammals, particularly humans. BACKGROUND OF THE INVENTION [0002] Serum cholesterol and serum triglyceride levels are important factors in the development of cardiovascular disease. In many clinical studies there is a positive correlation between plasma triglycerides and the incidence of cardiovascular disease [1]. Elevated plasma triglyceride level is frequently associated with other atherogenic factors including elevated low-density lipoprotein (LDL)-cholesterol, reduced high-density lipoprotein (HDL)-cholesterol, and small LDL particles [2, 3]. There is growing acceptance that triglycerides act in a synergistic fashion with these other lipid risk factors to increase the incidence of cardiovascular disease [4, 5]. Hypertriglyceridemia usually occurs because of insulin resistance, which leads to overproduction of very low-density lipoproteins (VLDL) by the liver [3]. Treatment involves lifestyle changes to decrease body weight and to increase physical activity, both of which improve insulin sensitivity. Drug therapy to lower triglycerides involves the use of fibrates or nicotinic acid [6]. [0003] A number of clinical studies convincingly establish plasma cholesterol and LDL-cholesterol as independent risk factors for coronary heart disease [7]. Pharmacological agents, called statins, lower total plasma cholesterol by inhibiting the synthesis of cholesterol by the liver. The statins reduce the morbidity and mortality rate from cardiovascular disease in high risk, hypercholesterolemic patients [8, 9], but also in persons who exhibit "average" cholesterol levels [10]. Another approach is to interfere with the intestinal absorption of cholesterol. Certain phytosterols (plant sterols) such as stigmasterol and .beta.-sitosterol lower serum cholesterol act by inhibiting absorption of both dietary and biliary cholesterol from the small intestine [11]. [0004] With respect to the most appropriate form of phytosterols for lowering serum cholesterol, some reports indicate that free phytosterols reduce serum cholesterol in animals and humans [12, 13]. However, there is also evidence to indicate that a sterol esterified with a fatty acid may be more effective [14]. Trials show that phytosterol esters of plant fatty acids obtained from canola oil, when incorporated into food such as margarine or mayonnaise, lower total cholesterol and LDL-cholesterol levels by about 10 and 15 percent, respectively [15, 16]. U.S. Pat. No. 5,502,045 (Miettinen et al., issued Mar. 26, 1996) discloses the use of sitostanol esters of canola oil to lower serum cholesterol. Benecol.TM. (Raisio Benecol Ltd., Raisio, Finland), a margarine that contains such compounds, is now on the market. [0005] The mechanism by which phytosterols or phytosterol esters inhibit absorption of dietary cholesterol by the digestive tract is not fully understood but may involve competitive inhibition of cholesterol uptake from the Intestinal lumen or inhibition of cholesterol esterification in the intestinal mucosa [12]. It is known that phytosterols themselves are only poorly absorbed. Vanhanen et al. [17] report that phytosterol esters may also be poorly absorbed by the intestinal tract based on postprandial measurements of .beta.-sitostanol in plasma. A direct measure of phytosterol ester uptake by the digestive tract has not been reported. [0006] When phytosterols are esterified with fatty acids from plant sources such as canola, the long-chain polyunsaturated fatty acids (LCPUFAs) that are incorporated are predominantly of the omega-6 series. Omega-6 fatty acids do not affect plasma triglycerides. Research to date on fatty acid esters of sterols has focused only on the efficacy of the sterol in lowering cholesterol. SUMMARY OF THE INVENTION [0007] The present invention provides a nutritional supplement comprising a sterol and an omega-3 fatty acid, or an ester thereof, for lowering cholesterol and triglyceride levels in the bloodstream of a subject. [0008] The present invention also provides a method of lowering cholesterol and triglyceride levels in the bloodstream of a subject, the method including the step of administration of an effective amount of a nutritional supplement comprising a sterol and an omega-3 fatty acid, or an ester thereof, to a subject. [0009] The present invention also provides the use of the nutritional supplement defined herein for lowering cholesterol and triglyceride levels in the bloodstream of a subject. [0010] The present invention further provides a foodstuff composition comprising the nutritional supplement defined herein and a foodstuff, the nutritional value of the foodstuff being enhanced by incorporation of the nutritional supplement defined herein. [0011] The present invention further provides the use of the nutritional supplement defined herein in the manufacture of a foodstuff composition. [0012] The subject is preferably a mammal, more preferably a human. [0013] Sterols are not very soluble in lipid, which complicates their use in lipid-based foods. A mixture of a sterol and a free omega-3 fatty acid, which typically forms a paste at a molar ratio of 1:1, may be used. If a mixture is used, the omega-3 fatty acid can be a free acid or can be in ester form, preferably a succinimidyl, triglyceride, (C.sub.3-C.sub.12)cycloalkyl or (C.sub.1-C.sub.8)alkyl ester, more preferably an ethyl ester. In the mixture, the molar ratio range of omega-3 fatty acid, or an ester thereof, to sterol should be about 0.5 to 8 preferably 0.76 to 6.4, more preferably 1 to 2. [0014] Preferably, the sterol and the omega-3 fatty acid are together in the form of an ester. The sterol esters of the present invention are highly fat-soluble and represent a bifunctional species, since they lower both serum cholesterol and serum triglyceride levels in the bloodstream. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS [0015] The sterols used to prepare the nutritional supplement of the present invention are preferably phytosterols, and preferably have a perhydrocyclopentanophenanthrene ring system as shown below in the compound of formula I: wherein the dashed line is a single or double bond and R is a (C.sub.1-C.sub.10)alkyl, substituted (C.sub.1-C.sub.10)alkyl, (C.sub.2-C.sub.10)alkenyl or substituted (C.sub.2-C.sub.10)alkenyl group. [0016] In the present application, the term "sterols" includes sterols in reduced form (stanols), preferably .beta.-sitostanol or fucostanol (reduced fucosterol). [0017] One or more sterols can be used to prepare the nutritional supplement. The term "phytosterols" includes sterols from terrestrial or marine plants, seaweed, microalgae, etc. Preferably, the sterol is stigmasterol, sitosterol or fucosterol, as shown below, or .beta.-sitostanol or fucostanol [0018] Fucosterol is abundant in brown algae. Prior to esterification with the omega-3 fatty acid, fucosterol can be reduced to fucostanol. Preferably, the reduction is carried out using hydrogen gas in the presence of a suitable catalyst such as palladium on charcoal (Pd/C), but other reduction processes that ultimately yield a food-quality ester, after purification if necessary, may be used. [0019] The nutritional supplement of the present invention comprises one or more omega-3 fatty acids, and is preferably an ester of an acid of the formula: wherein R.sup.1 is a (C.sub.3-C.sub.40)alkenyl group comprising at least one double bond, more preferably 2 to 5 double bonds. More preferably, the omega-3 fatty acid is stearidonic acid 18:4.omega.3 (SA), eicosapentaenoic acid 20:5.omega.3 (EPA) or docosahexaenoic acid 22:6.omega.3 (DHA). [0020] Omega-3 fatty acids, such as EPA and DHA, are long-chain polyunsaturated fatty acids (LCPUFAs) that are abundant in oily fish such as menhaden, salmon, tuna, and sardine, as well as in certain plants and microbes, such as articular fungi and microalgae. The preferred source of omega-3 fatty acids for the present invention is fish oil, more preferably a highly refined fish oil concentrate having approximately 65% omega-3 fatty acid content which is predominantly EPA and DHA in the form of triglyceride esters. These triglycerides are preferably converted to lower alkyl esters by known methods and used in an esterification with a sterol to form esters, which can be further purified if necessary, for use as nutritional supplements. Continue reading about Nutritional supplement for lowering serum triglyceride and cholesterol levels... Full patent description for Nutritional supplement for lowering serum triglyceride and cholesterol levels Brief Patent Description - Full Patent Description - Patent Application Claims Click on the above for other options relating to this Nutritional supplement for lowering serum triglyceride and cholesterol levels patent application. ###  How KEYWORD MONITOR works... a FREE service from FreshPatents1. Sign up (takes 30 seconds). 2. Fill in the keywords to be monitored. 3. Each week you receive an email with patent applications related to your keywords. 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